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This prospective randomized controlled multicenter study will be conducted to evaluate the effects of pre-emptive IV lidocaine dose on the incidence and severity of intraoperative headache that may occur after the extra-abdominal manual uterine fundal pressure in patients undergoing cesarean section under spinal anesthesia.
This fundal pressure was previously evaluated for its effect on maternal hemodynamics during cesarean section. The investigators observed in their practice that a complaint of headache is reported by a percentage of patients immediately after fundal pressure and fetal delivery. Despite its small percentage, it had a negative impact on the maternal experience.
The proposed mechanism of this headache may be attributed to the fundal pressure-induced cushing reflex, vasopressin response, or cerebral venous engorgement all resulted from the increase in intra-abdominal pressure which can be reflected on the intra-thoracic pressure and the intracranial pressure (ICP).
Lidocaine is a local anesthetic that, when given via intravenous (IV) route could attenuate the rise in ICP during tracheal suctioning, and decrease the optic nerve sheath diameter distension during endotracheal intubation and during laparoscopy. These effects could be established by reducing cerebral blood volume through its vasoconstrictive effects on the cerebral vasculature and by decreasing electrical activity and metabolic demands through its inhibitory effects on sodium channels.
The fundal pressure maneuver is supposed to produce pathophysiological changes that resemble the previously reported factors that led to ICP elevation (intubation and pneumo-peritoneum). So, this study will be conducted as the investigators hypothesize that the administration of single IV lidocaine dose shortly before uterine fundal pressure may attenuate the temporary rise in ICP which may decrease the incidence of headache.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine group | Experimental | IV lidocaine 1.5 mg/kg (diluted with 0.9% isotonic saline to a total volume of 10 ml) over 5 minutes with the start of skin incision |
|
| Control group | Placebo Comparator | IV 10 ml isotonic saline over the same period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine IV | Drug | IV lidocaine 1.5 mg/kg (diluted with 0.9% isotonic saline to a total volume of 10 ml) over 5 minutes with the start of skin incision after ensuring negative baseline headache. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of intraoperative headache | The incidence of intraoperative headache that may occur after fundal pressure application until the end of surgery will be recorded. | Up to the end of surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of intraoperative headache | The numerical rating scale (NRS) scores which is a 11-point scale ranging from 0= no pain to 10= most severe pain will be used to evaluate the severity of headache. | Up to the end of surgery. |
| The changes in optic nerve sheath diameter |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Osama M Rehab, MD | Contact | +201095210806 | osamarehab@med.tanta.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University Hospitals | Recruiting | Tanta | Gharbia Governorate | 31527 | Egypt |
The data will be available upon reasonable request from the corresponding author.
After completion of the study.
The data will be available upon reasonable request from the corresponding author.
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| ID | Term |
|---|---|
| D006261 | Headache |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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Quadruple
| Saline 0.9% | Other | IV 10 ml isotonic saline over 5 minutes with the start of skin incision after ensuring negative baseline headache. |
|
Optic nerve sheath diameter will be assessed by ultrasound before spinal block, at skin incision, after fetal delivery, and at the end of surgery. |
| Up to the end of surgery. |
| Incidence of shoulder pain | The incidence of shoulder pain that may occur intraoperatively and up to 24 hours after surgery will be recorded by asking the patients if they have any pain in their shoulder area. The numerical rating scale (NRS) scores which is a 11-point scale ranging from 0= no pain to 10= most severe pain will be used to evaluate the severity of shoulder pain. | Up to 24 hours after surgery. |
| Neonatal Apgar (appearance, pulse, grimace, activity, and respiration) scores | Neonatal Apgar scores which include five signs (appearance, pulse, grimace, activity, and respiration) will be recorded at 1 min and 5 minutes after delivery. Each sign has a score of 0, 1, 2 with a total score of 10. Scores more than 6 indicate normal good health. | Up to 5 minutes after delivery. |
| side effects | Nausea and vomiting, hypotension and bradycardia will be recorded | Intraoperative up to 1 hour after surgery. |
| Incidence of postoperative headache | The incidence of any headache that may occur from the end of surgery up to 24 hours after surgery will be recorded. | Up to 24 hours after surgery. |
| D017670 |
| Sodium Compounds |